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Fast Antibiotic Susceptibility Testing for Gram Negative Bacteremia Trial

NCT06174649 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2025-07-08

No results posted yet for this study

Summary

This study is a 2-arm, multicenter, multinational, prospective, randomized, controlled clinical trial. Hospitalized subjects with blood cultures growing Gram negative bacilli (GNB) will be randomized 1:1 to have the positive blood cultures characterized using standard of care (SOC) antimicrobial susceptibility testing (AST) vs. a rapid AST method known as Reveal™ in addition to SOC AST. The purpose of the FAST trial is to evaluate whether use of a rapid phenotypic AST improves clinical outcomes compared to use of SOC AST methods in clinical settings with high resistance rates.

Conditions

  • Gram-negative Bacteremia
  • Bloodstream Infection

Interventions

DIAGNOSTIC_TEST

Reveal

Reveal is a rapid AST method, which uses small molecule sensor technology to detect growth of bacterial populations by measuring volatile metabolites, and provides AST results in \~5 hours. Reveal™ is approved for clinical use in the European Union (EU) and Israel and approval is in process in India, and provides minimum inhibitory concentrations (MICs) for 28 antibiotics and 9 Gram negative species, that together account for \~90% of organisms causing Gram negative blood stream infections (BSI).

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Parexel

    collaborator INDUSTRY

  • BioMérieux

    collaborator INDUSTRY

  • Duke University

    lead OTHER

Principal Investigators

  • Ritu Banerjee, MD, PhD · Vanderbilt University Medical Center

  • Vance Fowler, MD · Duke Clinical Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-22
Primary Completion
2025-06-18
Completion
2025-06-18

Countries

  • Greece
  • India
  • Israel
  • Spain

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06174649 on ClinicalTrials.gov